Recalls / Class II
Class IID-1132-2015
Product
MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP); 37% Organically Bound Iodine For Gastrointestinal Radiography; Oral or rectal use only; Rx only; 30 mL; Single-Unit Container; ; Mallinckrodt Inc., St. Louis, MO 63042. NDC 0019-4816-04
- Brand name
- Md Gastroview
- Generic name
- Diatrizoate Meglumine And Diatrizoate Sodium
- Active ingredients
- Diatrizoate Meglumine, Diatrizoate Sodium
- Route
- Oral, Rectal
- NDC
- 0019-4816
- FDA application
- ANDA087388
- Affected lot / code info
- Lot #: B201B, Exp April 2015; B346D, Exp August 2015.
Why it was recalled
Labeling: incorrect or missing lot number and/or expiration date
Recalling firm
- Firm
- Mallinckrodt, Inc.
- Manufacturer
- Liebel-Flarsheim Company LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 675 James S McDonnell Blvd, N/A, Hazelwood, Missouri 63042-2301
Distribution
- Quantity
- 6600 bottles
- Distribution pattern
- Costa Rica
Timeline
- Recall initiated
- 2015-05-15
- FDA classified
- 2015-06-10
- Posted by FDA
- 2015-06-17
- Terminated
- 2017-07-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1132-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.